Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of ulcerative colitis (UC), established through tissue testing and either a camera examination of the bowel or imaging, at least 3 months before the screening visit.
• People whose UC is currently active and classified as mild-to-moderate, based on specific scoring measurements taken at screening (confirm with trial site for exact score details).
• People whose UC affects a portion of the bowel that starts at least 10 cm from the back passage.
• People who are either currently taking a stable dose of a standard UC medication called 5-ASA (taken by mouth), or for whom 5-ASA did not work well enough, or who have had a documented intolerance or reaction to it, or for whom it is medically unsuitable.
• People who are able to provide written consent to participate (for those under 18, a parent or legal guardian must provide consent).
• Women of childbearing potential, in countries where it is required, who agree to use an acceptable method of contraception as required by local rules until the end of treatment.

Who may not be able to join:

• People who have been diagnosed with Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.
• People who have a significant active infection in the digestive tract.
• People whose UC is classified as severe, or who only have inflammation in the very last section of the bowel (proctitis only), or whose most severe inflammation is in the upper parts of the colon, or who are planning a hospital admission at the time of screening.
• People who have had their entire colon removed, have a stoma or bowel pouch, or have had a large portion of their colon removed leaving less than 30 cm remaining.
• People who have fistulas, abscesses, diverticulitis, or bowel bleeding unrelated to UC.
• People with a history of colon cancer or high-grade abnormal cell changes in the colon.
• People who have previously been treated with any advanced UC medication, including anti-TNF drugs (e.g. infliximab), anti-integrin drugs (e.g. vedolizumab), anti-IL-12/23 or anti-IL-23 drugs (e.g. ustekinumab, risankizumab), JAK inhibitors (e.g. tofacitinib), or sphingosine-1-phosphate receptor modulators (e.g. etrasimod).
• People who have used a medication called sulfasalazine within 4 weeks before being assigned to a treatment group.
• People who have used corticosteroids or certain immune-modifying drugs (including thiopurines) within 6 weeks before being assigned to a treatment group, with an exception for those taking a low, stable dose of oral corticosteroids under specific conditions (confirm with trial site).
• People who have used antibiotics (other than topical/local use), prebiotics, or probiotics within 4 weeks before being assigned to a treatment group, or who expect to use them during the study, or who regularly use anti-diarrhoeal drugs, or who use any rectal treatments.
• People who have had a faecal microbiota transplant (a procedure involving donor stool) within the past 52 weeks before being assigned to a treatment group.
• People who have taken part in another clinical trial or received an experimental treatment within 30 days before screening, or within five times the clearance period of that experimental drug, whichever is longer.
• People with a weakened immune system, including those with HIV, active cancer, liver cirrhosis, or who are receiving chemotherapy.
• People with certain abnormal blood test results, including low white blood cell counts, low neutrophil counts, anaemia, low platelet counts, or a clotting disorder that significantly increases bleeding risk.
• People with ongoing or recent (within 3 months) kidney disease or reduced kidney function below a certain level (confirm with trial site).
• People with ongoing or recent (within 3 months) significant liver dysfunction, including certain elevated liver enzyme or bilirubin levels above set thresholds (confirm with trial site).
• People with significant bone marrow disease that is progressing or not controlled, or anyone who has had a solid organ or bone marrow transplant.
• People with active intravenous drug use or alcohol use disorder, as assessed by the study doctor.
• People who are pregnant or breastfeeding at the time of joining the study.
• People whom the study doctor considers unsuitable for the trial for any other reason.
• Employees (or their close relatives) of the study doctor, study centre, research organisation running the trial, or the company sponsoring the trial.

Important: Always verify eligibility with the trial site directly before applying.